Sasank Chinnamalreddygari

Lead Quality Engineer @Medicom Group

London, ON, CA

Quality System Development & Implementation:Assist in the establishment and implementation of an electronic Quality Management System (eQMS) in compliance with ISO 13485 and applicable regulatory standards (Health Canada, FDA, etc.).Draft, review, and implement Standard Operating Procedures (SOPs), Work Instructions, and Quality Manuals.Validation & Qualification:Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, utilities, and processes.Support validation of manufacturing processes for nitrile glove production, including mixing, dipping, curing, and packaging.Regulatory Compliance:Ensure compliance with medical device regulations including Health Canada Medical Device Regulations (CMDR), FDA 21 CFR Part 820, and ISO 13485.Assist in preparation for regulatory inspections and certification audits.Documentation & Records Management:Maintain accurate and audit-ready documentation of all quality-related activities.Control quality documents through eQMS and ensure timely revision and approval workflows.Risk Management & Quality Planning:Participate in risk assessments (FMEA) and support implementation of control measures during facility and process startup.Contribute to Quality Plans and startup timelines to ensure readiness for production launch.Training & Support:Help train cross-functional teams on quality processes and Good Manufacturing Practices (GMP).Support ongoing improvements in quality awareness and regulatory readiness across the site.Continuous Improvement:Identify quality system gaps and propose corrective/preventive actions.Work collaboratively with engineering, production, and regulatory teams to establish a culture of quality from the ground up.

University of Windsor

Master, Mechanical Engineering

Sri Chandrasekharendra Saraswathi Viswa Mahavidyalaya, Kancheepuram

Bachelor, Mechanical Engineering